Pro-V, Coat IntraOral MakerPkg

Basic Information

• Brand Name: Pro-V, Coat IntraOral MakerPkg
• Primary DI: D757H4011P1
• Version / Model: H-4011P
• Catalog Number: H-4011P
• Company Name: BISCO INC.
• Labeler DUNS: 053529939
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-06-12
• Public Version: 5
• Public Version Date: 2022-01-31
• Public Version Status: Update
• Public Device Record Key: 0259183a-4a84-47ec-87bd-9d283160ad11
• Distribution End Date: 2022-01-17

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
EBG	CROWN AND BRIDGE, TEMPORARY, RESIN	Dental	872.3770	2

GMDN Terms

Code	Name	Definition	Implantable	Status
62375	Dental coating, bond-reduction	A non-sterile, aqueous solution intended to be applied to a prepared tooth immediately prior to application of a temporary dental restoration (e.g., resin dental inlay) to prevent formation of a strong bond between the tooth and restoration, and therefore facilitate atraumatic removal of the provisional restoration. Also referred to as a dental separating medium, it may also help prevent microbial penetration of the tooth. After application, this device cannot be reused.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	D757H4011P1	HIBCC

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K103514	000

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			sixe text

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 20 – 25 Degrees Celsius